Domperidone for Gastroparesis in Solid Organ Transplantation

This study has been terminated.
(Lack of perceived need for domperidone in this population)
Sponsor:
Information provided by (Responsible Party):
David J. Lederer, M.D., Columbia University
ClinicalTrials.gov Identifier:
NCT00552422
First received: October 31, 2007
Last updated: October 14, 2013
Last verified: October 2013

October 31, 2007
October 14, 2013
March 2007
September 2010   (final data collection date for primary outcome measure)
Symptomatic improvement [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Symptomatic improvement [ Time Frame: 2 months ]
Complete list of historical versions of study NCT00552422 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Domperidone for Gastroparesis in Solid Organ Transplantation
Domperidone for Gastroparesis Associated With Solid Organ Transplantation

The purpose of this study is to examine the clinical response to domperidone in solid organ transplant recipients with gastroparesis.

After heart or lung transplantation, the stomach tends to empty much slower than normal. This slow emptying is called "gastroparesis." Gastroparesis is uncomfortable and often leads to nausea and vomiting. In addition to drastically impacting quality of life, severe nausea and vomiting can also lead to malnutrition and an inability to take oral medications, contributing to complications of transplantation. Treatments for gastroparesis include both medical and surgical therapies that work for some but not all patients.

Domperidone is a peripheral D2 antagonist that improves the emptying of the stomach in patients with gastroparesis. Domperidone is not FDA approved at this time. Some patients have developed lifethreatening abnormal heart rhythms after receiving domperidone intravenously. This problem has not been seen with domperidone given by mouth.

We propose to administer domperidone by mouth at standard doses to solid organ transplant patients who have gastroparesis that is not responsive to standard medical therapies or who experience adverse drug side effects. This study will not be blinded (open-label) and has a single treatment arm (no control or placebo group).

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gastroparesis
  • Gastroesophageal Reflux
Drug: domperidone
10mg orally four times per day
Experimental: Domperidone Arm
Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with significant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with significant renal impairment will be 20mg twice a day.
Intervention: Drug: domperidone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • gastroparesis or gastroesophageal reflux that is refractory to standard therapy.
  • signed informed consent

Exclusion Criteria:

  • serious cardiac arrhythmias
  • clinically significant bradycardia, sinus node dysfunction, or heart block.
  • prolonged QTc
  • clinically significant electrolyte disorders.
  • gastrointestinal hemorrhage or obstruction.
  • prolactinoma
  • pregnant or breast feeding female
  • known allergy to domperidone.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00552422
AAAC3728
No
David J. Lederer, M.D., Columbia University
David J. Lederer, M.D.
Not Provided
Principal Investigator: David J Lederer, M.D. Columbia University
Columbia University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP